Child BehaviorNCT05662436
Protocol for the Open Sky School
A study testing Open Sky School program in people with Child Behavior, run by McGill University at 1 site in Canada.
Trial summary
The goal of this a randomized controlled trial to test the effectiveness of a nature-based intervention called Open Sky School to reduce mental health problems among elementary school children. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Child Behavior
- What is being tested?
- Open Sky School program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteCanada
- Study dates
- 20 Dec 2022to 23 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Additional inclusion criteria for schools are: (a) access to a natural environment (e.g., park, wooden area) on school grounds or within 1 km of the school and (b) having 6th grade teachers provide informed and written consent to participate in this study. Inclusion criteria for children are (a) enrollment in 6th grade, (b) providing their assent and (c) having their parents or legal guardians provide informed written consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
Marie-Claude Geoffroy, PhD, marie-claude.geoffroy@mcgill.ca
About this study
Official title: Protocol for the Open Sky School: A Two-arm Clustered Randomized Controlled Trial to Test the Effectiveness of a Nature-based Intervention on Mental Health of Elementary School Children
The goal of this a randomized controlled trial to test the effectiveness of a nature-based intervention called Open Sky School to reduce mental health problems among elementary school children. More specifically a two-arm clustered randomized controlled trial will be conducted in elementary schools across Québec, Canada. Following informed consent by teachers, parents and students, schools will be randomly assigned 1:1 to the intervention or the control group with a total of 2500 6th grade students and 100 teachers expected to participate. The primary and secondary research questions are as follows.
The primary research question :
Read more
- Is the intervention effective in reducing mental health problems in children from pre-to-post test (Social Behavior Questionnaire: self and teacher reports) ?
The secondary research questions:
- Is the intervention effective in improving children's depression, positive and negative affect, nature connectedness. eco-anxiety and pro-environmental behaviors ?
- Is the intervention effective in improving teachers' well-being and affect ?
- Are the benefits to children sustained benefits at 3 months follow-up ?
- Is the primary question moderated by child's sex, child's disability status, the green space of neighbourhoods, the school's socio-economic position and teacher's experience wtih outdoor education ?
The intervention will take place outdoors in a green-space (2 hours per week for 12 weeks) and include a toolkit of 30 activities to foster well-being (e.g. mindfulness) and academic competencies (e.g. mathematics). The control group will engage in teaching-as-usual and will be provided with the activity toolkit after the trial has been conducted. Questionnaires will be administered to students before, immediately after and 3 months after the intervention in both the control and intervention groups. Teachers in both groups will complete questionnaires before and immediately after the intervention.
- Conditions
- Child Behavior
- Being tested
- Open Sky School program
- Keywords
- school-based intervention, mental health, children, randomized controlled trial, nature, outdoor education, elementary-school children, greenspace
- Medical subject headings
- Child Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Sky School programOther
Teachers lead students in 2 hours of outdoor activities per week for 12 weeks, as detailed in the arm description
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The exposure to nature consists of teachers bringing their students to the highest quality green space within 1 km of a school which could be located on or off campus. The class will spend a total of 2 hours (i.e. 2 one hour visits or one 2 hours visits) per week for 12 weeks (transportation included). The teacher be provided with a toolkit of activities (mental health and academic competencies) that they will carry out with their students. Teachers will be provided with training and support. Receives: Other: Open Sky School program |
| Control | No intervention | Six months after the inception of the trial, elementary schools (and their teachers) in the control condition will receive an unguided version of the intervention, supplemented by an online peer support group. As the children of the control group will by then be in high school with different teachers, we will provide them with a toolkit of 10 mental health activities that they can practice alone, in addition of support via video-conference, phone or email if they require help practicing the activities from a member of the research team. As in the intervention group, we will provide support by licensed psychologists to any children who report high levels of psychological distress and orient children to appropriate services if needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Child Mental Health at 3 months
The Social Behavior Questionnaire is a 30 items questionnaire that will be used to assess a range of mental health symptoms in children. The frequency of children's symptoms over the last 2 months is rated on a scale 3-point (never/not true = 0, sometimes/somewhat true = 1, often/very true = 2). Overall symptoms will be examined as outcomes, as well as internalizing symptoms (emotional distress and withdrawal; 11 items), externalizing symptoms (impulsive/hyperactive/inattentive and disruptive behaviors; 13 items), and social behaviors (pro-social behavior and peer relationships; 6 items). Ratings will be obtained by both child and teacher reports which will be analyzed separately.
Measured: Baseline, 3 months
Secondary outcomes (19)
Change from Baseline Child Mental Health at 6 months
The Social Behavior Questionnaire is a 30 items questionnaire that will be used to assess a range of mental health symptoms in children. The frequency of children's symptoms over the last 2 months is rated on a scale 3-point (never/not true = 0, sometimes/somewhat true = 1, often/very true = 2). Overall symptoms will be examined as outcomes, as well as internalizing symptoms (emotional distress and withdrawal; 11 items), externalizing symptoms (impulsive/hyperactive/inattentive and disruptive behaviors; 13 items), and social behaviors (pro-social behavior and peer relationships; 6 items). Ratings will be obtained the child self report version.
Measured: Baseline, 6 months
Change from Baseline Child Depressive symptoms at 3 months
The Children's Depression Inventory-Short Version (CDI-S) includes 13 items that will be used to assess cognitive, affective and behavioral signs of depression in children. The CDI-S has good convergent, discriminate and factorial validity among children. Children consider how they were feeling over the last 2 weeks and respond on a 3-point scale (e.g. 1=I hate myself; 2=I don't like myself; 3=I like myself).
Measured: Baseline, 3 months
Change from Baseline Child Depressive Symptoms at 6 months
The Children's Depression Inventory-Short Version (CDI-S) includes 13 items that will be used to assess cognitive, affective and behavioral signs of depression in children. The CDI-S has good convergent, discriminate and factorial validity among children. Children consider how they were feeling over the last 2 weeks and respond on a 3-point scale (e.g. 1=I hate myself; 2=I don't like myself; 3=I like myself).
Measured: Baseline, 6 months
Change from Baseline Child Positive and Negative Affect at 3 months
The Positive and Negative Affect Schedule for Child (PANAS-C) is a 20-item scale that will be used to assess positive (e.g., "excited") and negative (e.g., "upset") affect which has good convergent and discriminate validity among children. Children will indicate to what extent they feel over the last weeks (1=very slightly or not at all; 5=extremely).
Measured: Baseline, 3 months
Change from Baseline Child Positive and Negative Affect at 6 months
The Positive and Negative Affect Schedule for Child (PANAS-C) is a 20-item scale that will be used to assess positive (e.g., "excited") and negative (e.g., "upset") affect which has good convergent and discriminate validity among children. Children will indicate to what extent they feel over the last weeks (1=very slightly or not at all; 5=extremely).
Measured: Baseline, 6 months
Change from Baseline Child Connection with Nature at 3 Months
The Nature Connection Index (NCI) is a self-report questionnaire including 6 items that will be used to assess connectedness to nature. The scale has good validity and reliability among children. Participants respond to affirmations (e.g. nature always makes me happy) using a 7-point scale (1=strongly agree; 7=strongly disagree).
Measured: Baseline, 3 months
Change from Baseline Child Connection with Nature at 6 Months
The Nature Connection Index (NCI) is a self-report questionnaire including 6 items that will be used to assess connectedness to nature. The scale has good validity and reliability among children. Participants respond to affirmations (e.g. nature always makes me happy) using a 7-point scale (1=strongly agree; 7=strongly disagree).
Measured: Baseline, 6 months
Change from Baseline Child Pro-environmental Behaviors at 3 Months
Pro-environmental attitude and behaviors will be measured with two questionnaires. The first is a brief 6-item measure developed in a recent study, asking children to report the frequency they made an effort to conserve water, energy and recycle trash (1=always; 5=never) and the extent to which they agree that they are ready to volunteer, give money and talk to their entourage to protect nature (1=strongly agree; 4=strongly disagree). The second includes 4 questions specific to climate change which were adapted from a previous study and developed by experts in the field. Children report the extent to which they are worried about climate change (1=not at all worried; 4=extremely worried), that these worries motivate them to engage in pro-environmental behaviors or activism (1=not at all; 4=a lot) and that they feel capable of making behavioral changes to help the environment (1=strongly disagree; 4=strongly agree).
Measured: Baseline, 3 months
Change from Baseline Child Pro-environmental Behaviors at 6 Months
Pro-environmental attitude and behaviors will be measured with two questionnaires. The first is a brief 6-item measure developed in a recent study, asking children to report the frequency they made an effort to conserve water, energy and recycle trash (1=always; 5=never) and the extent to which they agree that they are ready to volunteer, give money and talk to their entourage to protect nature (1=strongly agree; 4=strongly disagree). The second includes 4 questions specific to climate change which were adapted from a previous study and developed by experts in the field. Children report the extent to which they are worried about climate change (1=not at all worried; 4=extremely worried), that these worries motivate them to engage in pro-environmental behaviors or activism (1=not at all; 4=a lot) and that they feel capable of making behavioral changes to help the environment (1=strongly disagree; 4=strongly agree).
Measured: Baseline, 6 months
Child's Appreciation of the Program
We designed one item for children to self-report the frequency that they appreciated the intervention (1=not at all; 4=always) that will be administered in the intervention group at post-test.
Measured: 3 months
Change from Baseline Teacher Well-being at 3 Months
The World Health Organization Well-Being Index (WHO-5) is a 5-item self-report measure that will assess of wellbeing for adults. The WHO-5 is a widely used, valid and reliable measure that is sensitive to change. Participants indicate the frequency of their feelings (e.g. in a good mood) over the last two weeks (5=all the time; 0=never).
Measured: Baseline, 3 months
Change from Baseline Teacher Positive and Negative Affect at 3 Months
The Positive and Negative Affect Schedule (PANAS) is a 20-item scale that will be used to assess positive (e.g., "excited") and negative (e.g., "upset") affect which has well-established good psychometric properties. Teachers will indicate to what extent they feel over the last weeks (1=very slightly or not at all; 5=extremely).
Measured: Baseline, 3 Months
Teacher's Enjoyment of Outdoor Education
An adapted version of the Enjoyment of Teaching Mathematics Scale will be used for teachers from the intervention group at post-test to self-report their enjoyment of teaching outdoors (e.g. I really like teaching outdoors) with 5 items on a 5 point scale (1=strongly agree; 5=strongly disagree).
Measured: 3 months
Teacher's Qualifications and Experience
We designed questions about teachers qualification and experience teaching in general. Higher scores indicate higher levels of experience.
This will be investigated as a moderator.
Measured: Baseline
Teacher's Experience Teaching Outdoors
Teachers' experience with outdoor teaching over the last 3 years (e.g. context, duration) (e.g. did you practice outdoor education in autumn 2022?) and outdoor activities practiced in their leisure time will be assessed with a 6 questions that were successfully used in a previous study on school based outdoor education. Higher scores indicate higher levels of experience outdoors. This will be investigated as a moderator.
Measured: Baseline
Green Space of Neighborhoods
The Normalized Difference Vegetation Index (NDVI) will be used to quantify the density of green vegetation associated with the school's zip code. The widely used NDVI is based on the land surface reflectance of colors which is drawn from satellite images of the earth's surface. The index varies between +1 and -1 with higher values indicating higher green vegetation density. We will use 2019 satellite images which are available via the Consortium CANUE. This will be investigated as a moderator.
Measured: Baseline
Disability Status of Children
Children formally diagnosed as having a physical or mental disability (e.g. intellectual deficiency) or having adaptation disorders (e.g. conduct disorders) or learning disorders (e.g. language deficits) will be identified via their school records. This will be investigated as a moderator.
Measured: Baseline
Child's Sex
The children's sex (male, female) will be obtained via school records. This will be investigated as a moderator.
Measured: Baseline
School's Level of Socio-economic Deprivation
School's level of deprivation will be quantified using a ranking provided by the Ministry of Education and Higher Education. The ranking is based on a composite score incorporating the proportion of students within each school whose mother completed high-school and whose both parents are employed full time. Schools are classified on a scale ranging from 1 (lowest deprivation) to 10 (highest deprivation) and scores of 8 to 10 are considered as disadvantaged. This will be investigated as a moderator
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start20 Dec 2022 (estimated)
- Primary completion20 Jun 2023 (estimated)
- Study completion23 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Observatory for Children's Education and Health
- Responsible party
- Sponsor
- Investigators
- Marie-Claude Geoffroy, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662436
- Sponsor's protocol ID
- 468540
- Status last verified
- Dec 2022
- First submitted
- 25 Nov 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loose T, Fuoco J, Malboeuf-Hurtubise C, Ayotte-Beaudet JP, Gauvin L, Chadi N, Ouellet-Morin I, Masse B, Cote SM, Geoffroy MC. A Nature-Based Intervention and Mental Health of Schoolchildren: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2444824. doi: 10.1001/jamanetworkopen.2024.44824.
PubMed 39546315Loose T, Cote S, Malboeuf-Hurtubise C, Beaudet JA, Lessard G, Chadi N, Gauvin L, Morin IO, Geoffroy MC. Protocol for the Open Sky School: a two-arm clustered randomized controlled trial to test the effectiveness of a nature-based intervention on mental health of elementary school children. BMC Public Health. 2023 Feb 3;23(1):236. doi: 10.1186/s12889-023-15033-y.
PubMed 36737725
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for the Open Sky School: A Two-arm Clustered Randomized Controlled Trial to Test the Effectiveness of a Nature-based Intervention on Mental Health of Elementary School Children
- ClinicalTrials.gov ID
- NCT05662436
- Acronym / sponsor ID
- 468540
- Conditions
- Child Behavior
- Keywords
- school-based intervention, mental health, children, randomized controlled trial, nature, outdoor education, elementary-school children, greenspace
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Observatory for Children's Education and Health
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 20 Jun 2023 (estimated)
- Study completion
- 23 Sep 2023 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this a randomized controlled trial to test the effectiveness of a nature-based intervention called Open Sky School to reduce mental health problems among elementary school children. More specifically a two-arm clustered randomized controlled trial will be conducted in elementary schools across Québec, Canada. Following informed consent by teachers, parents and students, schools will be randomly assigned 1:1 to the intervention or the control group with a total of 2500 6th grade students and 100 teachers expected to participate. The primary and secondary research questions are as follows.
The primary research question :
- Is the intervention effective in reducing mental health problems in children from pre-to-post test (Social Behavior Questionnaire: self and teacher reports) ?
The secondary research questions:
- Is the intervention effective in improving children's depression, positive and negative affect, nature connectedness. eco-anxiety and pro-environmental behaviors ?
- Is the intervention effective in improving teachers' well-being and affect ?
- Are the benefits to children sustained benefits at 3 months follow-up ?
- Is the primary question moderated by child's sex, child's disability status, the green space of neighbourhoods, the school's socio-economic position and teacher's experience wtih outdoor education ?
The intervention will take place outdoors in a green-space (2 hours per week for 12 weeks) and include a toolkit of 30 activities to foster well-being (e.g. mindfulness) and academic competencies (e.g. mathematics). The control group will engage in teaching-as-usual and will be provided with the activity toolkit after the trial has been conducted. Questionnaires will be administered to students before, immediately after and 3 months after the intervention in both the control and intervention groups. Teachers in both groups will complete questionnaires before and immediately after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Open Sky School programThe exposure to nature consists of teachers bringing their students to the highest quality green space within 1 km of a school which could be located on or off campus. The class will spend a total of 2 hours (i.e. 2 one hour visits or one 2 hours visits) per week for 12 weeks (transportation included). The teacher be provided with a toolkit of activities (mental health and academic competencies) that they will carry out with their students. Teachers will be provided with training and support. |
| Control | No intervention | –Six months after the inception of the trial, elementary schools (and their teachers) in the control condition will receive an unguided version of the intervention, supplemented by an online peer support group. As the children of the control group will by then be in high school with different teachers, we will provide them with a toolkit of 10 mental health activities that they can practice alone, in addition of support via video-conference, phone or email if they require help practicing the activities from a member of the research team. As in the intervention group, we will provide support by licensed psychologists to any children who report high levels of psychological distress and orient children to appropriate services if needed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Sky School programTeachers lead students in 2 hours of outdoor activities per week for 12 weeks, as detailed in the arm description | Other | Intervention group |
Primary outcome
Change from Baseline Child Mental Health at 3 months
Time frame: Baseline, 3 months
The Social Behavior Questionnaire is a 30 items questionnaire that will be used to assess a range of mental health symptoms in children. The frequency of children's symptoms over the last 2 months is rated on a scale 3-point (never/not true = 0, sometimes/somewhat true = 1, often/very true = 2). Overall symptoms will be examined as outcomes, as well as internalizing symptoms (emotional distress and withdrawal; 11 items), externalizing symptoms (impulsive/hyperactive/inattentive and disruptive behaviors; 13 items), and social behaviors (pro-social behavior and peer relationships; 6 items). Ratings will be obtained by both child and teacher reports which will be analyzed separately.
19 secondary outcomes
Change from Baseline Child Mental Health at 6 months
Time frame: Baseline, 6 months
Change from Baseline Child Depressive symptoms at 3 months
Time frame: Baseline, 3 months
Change from Baseline Child Depressive Symptoms at 6 months
Time frame: Baseline, 6 months
Change from Baseline Child Positive and Negative Affect at 3 months
Time frame: Baseline, 3 months
Change from Baseline Child Positive and Negative Affect at 6 months
Time frame: Baseline, 6 months
Change from Baseline Child Connection with Nature at 3 Months
Time frame: Baseline, 3 months
Change from Baseline Child Connection with Nature at 6 Months
Time frame: Baseline, 6 months
Change from Baseline Child Pro-environmental Behaviors at 3 Months
Time frame: Baseline, 3 months
Change from Baseline Child Pro-environmental Behaviors at 6 Months
Time frame: Baseline, 6 months
Child's Appreciation of the Program
Time frame: 3 months
Change from Baseline Teacher Well-being at 3 Months
Time frame: Baseline, 3 months
Change from Baseline Teacher Positive and Negative Affect at 3 Months
Time frame: Baseline, 3 Months
Teacher's Enjoyment of Outdoor Education
Time frame: 3 months
Teacher's Qualifications and Experience
Time frame: Baseline
Teacher's Experience Teaching Outdoors
Time frame: Baseline
Green Space of Neighborhoods
Time frame: Baseline
Disability Status of Children
Time frame: Baseline
Child's Sex
Time frame: Baseline
School's Level of Socio-economic Deprivation
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 39546315Loose T, Fuoco J, Malboeuf-Hurtubise C, Ayotte-Beaudet JP, Gauvin L, Chadi N, Ouellet-Morin I, Masse B, Cote SM, Geoffroy MC. A Nature-Based Intervention and Mental Health of Schoolchildren: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2444824. doi: 10.1001/jamanetworkopen.2024.44824.
- Derived from this study: PubMed 36737725Loose T, Cote S, Malboeuf-Hurtubise C, Beaudet JA, Lessard G, Chadi N, Gauvin L, Morin IO, Geoffroy MC. Protocol for the Open Sky School: a two-arm clustered randomized controlled trial to test the effectiveness of a nature-based intervention on mental health of elementary school children. BMC Public Health. 2023 Feb 3;23(1):236. doi: 10.1186/s12889-023-15033-y.
- Individual participant dataSharing planned: No
Related trials for Child Behavior
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Claude Geoffroy, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Sky School program in people with Child Behavior, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Claude Geoffroy, PhD (514-691-5931, marie-claude.geoffroy@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Child Mental Health at 3 months (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05662436, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.